FDA Commissioner: Use Generic Alternatives to Recalled J&J Meds

By Katherine Hobson

The head of the FDA yesterday urged parents to use generic alternatives to the Johnson & Johnson children’s medicines being recalled for manufacturing problems, the WSJ reports.

A quick recap: late last week J&J said it was recalling certain children’s and infant’s liquid products — including Tylenol drops, Motrin suspension and Zyrtec syrup — because they may have higher concentration of the active ingredient than they’re supposed to, may contain inactive ingredients that don’t meet the company’s standards or may contain particles. (Here’s the list of recalled products.)

Yesterday the FDA said that an April inspection of the problematic plant, in Fort Washington, Pa., had turned up raw materials contaminated by certain bacteria that may cause infections, the WSJ reports. The raw materials were destined to be used in some of the Tylenol products under recall; the FDA says while the ingredients may have entered the manufacturing chain, final products inspected by J&J didn’t show signs of contamination.

The FDA also said 46 consumers had complained to the company about “foreign materials, black or dark specks” in products since June of last year.

Even with the latest findings, FDA head Margaret Hamburg still says the potential for harm is remote – but says that parents should sidestep the recalled products and use generic alternatives. The question for the company: will parents ever return to the name brand?

Comments (3 of 3)

Health care information technology has been ignored by the FDA, yet has killed more people than these supposedly tainted products. When is the FDA to inspect the vendors of computerized ordering devices and ascertain the national injury rate?

10:35 am May 5, 2010

Jim wrote :

They are being made an example of. The recall is voluntary and the FDA wording of what is wrong is very weak.

8:53 am May 5, 2010

Paul wrote :

I believe J & J needs to apologize, clean up their act in order to restore the my trust, and perhaps the public's trust!